PlainRecalls
FDA Devices Low Class III Terminated

smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Reported: October 10, 2018 Initiated: July 6, 2018 #Z-0073-2019

Product Description

smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Reason for Recall

"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
3,000 devices
Distribution
Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.. Recalled by Smiths Medical ASD Inc.. Units affected: 3,000 devices.
Why was this product recalled?
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 10, 2018. Severity: Low. Recall number: Z-0073-2019.